Recon: FDA approves Iovance’s cell therapy Amtagvi for solid tumors; Pfizer’s inflammatory bowel disease drug authorized in EU

• In ‘major milestone,’ FDA approves first cell therapy for solid tumors (STAT) (Endpoints)
• Key congressman blasts HHS for lack of cooperation on Covid-19 (STAT)
• FDA sets June decision deadline for potential full approval, label expansion of Sarepta’s Duchenne gene therapy (STAT)
• FDA approves Roche, Novartis' Xolair to prevent severe outcomes from common food allergies (Fierce Pharma)
• U.S. FDA approves AstraZeneca's Tagrisso-chemo combo (Reuters)
• GSK and others delist Orange Book patents after FTC targets protections on inhalers and epinephrine injectors (STAT)
• Senators call on FDA to address 'deluge of misleading promotions' on social media (STAT)

• Novartis, zeroing in on innovative meds, launches strategic review of India outfit (Fierce Pharma)
• Following FDA rejection, Sanofi and Regeneron's Dupixent gains Japanese approval in hives condition (Fierce Pharma)
• EU drug regulator to review Lilly's Mounjaro in multi-dose pen (Reuters)
• Five Key Meetings Offering EU Medtech Regulatory Insights Over Next Four Months (MedTech Insight)
• Philippines FDA Slashes Approval Timelines For Generic Drugs (Pink Sheet)
• England’s NICE Unconvinced That Sanofi’s Sarclisa Is Cost Effective After Cancer Drugs Fund Review (Pink Sheet)
• Data Exclusivity Demand In EFTA-India Deal: Access, Licensing, Other Implications (Pink Sheet)
• Australia Identifies HTA Challenges Posed By Emerging Technologies (Pink Sheet)
• Pfizer inflammatory bowel disease drug wins EU approval (Reuters)
• Novo Licenses to Almirall Potential First-in-Class Antibody Candidate (BioSpace)
• Opinion: The Promise and Challenges of CRISPR-Based Treatments (BioSpace)

• The complicated connections between weight loss drugs and mental health (STAT)
• Eli Lilly, Novo Nordisk get growth stock status on weight-loss drug boost (Reuters)
• Opioid cravings were reduced by anti-obesity drug in small study (STAT)
• Flagship Pioneering startup lays off a third of staff (STAT)
• Denali reports a PhII ALS fail as RIPK1 deal with Sanofi hits another bump (STAT)
• Gilead's $4.3B liver bet; WuXi under fire; Exscientia CEO’s ouster; Late Friday cell therapy approval; and more (Endpoints)
• US study uncovers 275 million entirely new genetic variants (Reuters)
• FDA Accepts BLA for AstraZeneca, Daiichi Sankyo’s ADC for NSCLC (BioSpace)
• How Will FDA’s Pivot to Overall Survival Affect Cancer Drug Development? (BioSpace)
• Gilead Suspends Patient Enrollment for Magrolimab in Solid Tumor Trials (BioSpace)

• News We’re Watching: CDRH’s Maisel Announces Retirement, Fresenius Clearance, Philips and Smiths Recalls (MedTech Insight)
• FOIA Claims Bring Electroshock Device Dispute Back To Courts (MedTech Insight)
• Chapter 11 Bankruptcy, Not A Party You Would Want An Invitae For (MedTech Insight)

• Banning surprise medical bills is raising costs elsewhere (STAT)
• Organon's Humira biosimilar gets exclusive spot on VA formulary (Endpoints)